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Project Title:

Human Gene Editing: Scientific, Medical and Ethical Considerations
PIN: IOM-HSP-15-10        

Major Unit:

Division of Behavioral and Social Sciences and Education
Division on Earth and Life Studies
Institute of Medicine
Policy and Global Affairs

Sub Unit: Board on Life Sciences
Board on Health Sciences Policy
Committee on Science, Technology and Law

RSO: Bowman, Katherine

Subject/Focus Area: Biology and Life Sciences; Health and Medicine; Policy for Science and Technology

Project Scope
The study will examine the scientific underpinnings as well as the clinical, ethical, legal, and social implications of the use of human genome editing technologies in biomedical research and medicine. It will address the following issues related to human gene editing, including editing of the human germline:

1. What is the current state of the science of human gene editing, as well as possible future directions and challenges to further advances in this research?
2. What are the potential clinical applications that may hold promise for the treatment of human diseases? What alternative approaches exist?
3. What is known about the efficacy and risks of gene editing in humans, and what research might increase the specificity and efficacy of human gene editing while reducing risks? Will further advances in gene editing introduce additional potential clinical applications while reducing concerns about patient safety?
4. Can or should explicit scientific standards be established for quantifying off-target genome alterations and, if so, how should such standards be applied for use in the treatment of human diseases?
5. Do current ethical and legal standards for human subjects research adequately address human gene editing, including germline editing? What are the ethical, legal, and social implications of the use of current and projected gene-editing technologies in humans?
6. What principles or frameworks might provide appropriate oversight for somatic and germline editing in humans? How might they help determine whether, and which applications of, gene editing in humans should or should not go forward? What safeguards should be in place to ensure proper conduct of gene-editing research and use of gene-editing techniques?
7. Provide examples of how these issues are being addressed in the international context. What are the prospects for harmonizing policies? What can be learned from the approaches being applied in different jurisdictions?

The committee will address these questions and prepare a report that contains its findings and recommendations.

The report will provide a framework based on fundamental, underlying principles that may be adapted and adopted by any nation that is considering the development of guidelines. The report will also include a focus on advice for the United States.

The project is sponsored by the Greenwall Foundation and the U.S. Food and Drug Administration. Additional sponsors are expected to be announced shortly. The approximate starting date for the project is November 2015. A final report will be issued at the end of the project in approximately 12 months.

Project Duration: 12 months    

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Committee Membership
Committee Membership

 Meeting 1 - 12/02/2015
 Meeting 2 - 02/11/2016
 Meeting 3 - 04/29/2016
 Meeting 4 - 07/12/2016
 Meeting 5 - 09/24/2016


Reports having no URL can be seen
at the Public Access Records Office
Human Genome Editing: Science, Ethics, and Governance